Trial Outcomes & Findings for Semaglutide in CFRD (NCT NCT05788965)

NCT ID: NCT05788965

Last Updated: 2026-01-21

Results Overview

Change in weight before and 12 weeks post treatment

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 8 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2026-01-21

Participant Flow

Participant milestones

Measure	Semaglutide Treatment This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD. Semaglutide: glucagon-like peptide 1 (GLP-1) receptor agonist
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Semaglutide in CFRD

Baseline characteristics by cohort

Measure	Semaglutide Treatment n=8 Participants This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD. Semaglutide: glucagon-like peptide 1 (GLP-1) receptor agonist
Age, Categorical <=18 years	0 Participants n=37 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=37 Participants
Age, Categorical >=65 years	0 Participants n=37 Participants
Age, Continuous	40.4 years STANDARD_DEVIATION 5.2 • n=37 Participants
Sex: Female, Male Female	4 Participants n=37 Participants
Sex: Female, Male Male	4 Participants n=37 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants
Race (NIH/OMB) Asian	0 Participants n=37 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants
Race (NIH/OMB) Black or African American	0 Participants n=37 Participants
Race (NIH/OMB) White	8 Participants n=37 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants

PRIMARY outcome

Timeframe: 12 weeks

Change in weight before and 12 weeks post treatment

Outcome measures

Measure	Semaglutide Treatment n=8 Participants This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD. Semaglutide: glucagon-like peptide 1 (GLP-1) receptor agonist
Weight	-4.6 kilograms Standard Deviation 1.9

PRIMARY outcome

Timeframe: 12 weeks

Change in BMI before and 12 weeks post treatment

Outcome measures

Measure	Semaglutide Treatment n=8 Participants This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD. Semaglutide: glucagon-like peptide 1 (GLP-1) receptor agonist
BMI (kg/m2)	-1.8 kg/m2 Standard Deviation 0.9

SECONDARY outcome

Timeframe: 12 weeks

Change in CGM TIR before and 12 weeks post treatment. Outcome reflects the change in continuous glucose monitoring (CGM) time in range (TIR), measured at baseline and again 12 weeks after treatment initiation.

TIR is defined as the percentage of time glucose values are between 70 and 180 mg/dL

Outcome measures

Measure	Semaglutide Treatment n=8 Participants This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD. Semaglutide: glucagon-like peptide 1 (GLP-1) receptor agonist
CGM % Time in Target TIR)	7 percentage time in target Standard Deviation 10.5

SECONDARY outcome

Timeframe: 12 weeks

change in the percent of HbA1c before and 12 weeks post treatment

Outcome measures

Measure	Semaglutide Treatment n=8 Participants This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD. Semaglutide: glucagon-like peptide 1 (GLP-1) receptor agonist
A1c	-0.3 change in the percent of HbA1c Standard Deviation 0.3

Adverse Events

Semaglutide Treatment

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Semaglutide Treatment n=8 participants at risk This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD. Semaglutide: glucagon-like peptide 1 (GLP-1) receptor agonist
Gastrointestinal disorders Nausea	62.5% 5/8 • Number of events 8 • 12 weeks
Gastrointestinal disorders Constipation	25.0% 2/8 • Number of events 3 • 12 weeks
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • Number of events 2 • 12 weeks
Gastrointestinal disorders Heartburn	37.5% 3/8 • Number of events 3 • 12 weeks
Gastrointestinal disorders Vomiting	25.0% 2/8 • Number of events 2 • 12 weeks

Additional Information

Amir Moheet

University of Minnesota

Phone: 612-624-3209

Email: mohee002@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place